Access assembly having undercut structure

ABSTRACT

An assembly for accessing a body cavity is provided. The access assembly includes a flexible outer sleeve configured to be received through an opening in tissue. The outer sleeve defines a passageway therethrough and a notch formed about an inner surface thereof. The access assembly further includes a support plate configured for selective reception through the passageway of the outer sleeve and within the notch formed in the inner surface. The support plate defines at least a first opening configured to receive a surgical instrument therethrough.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 61/424,938 filed on Dec. 20, 2010, theentire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to access assemblies for use in surgicalprocedures. More particularly, the present disclosure relates to accessassemblies having an undercut structure.

2. Background of Related Art

Access assemblies configured for reception through an opening orincision into a body cavity are known, as are methods of inserting theaccess assemblies therethrough. Traditionally, access assemblies includea rigid cannula that is received through the tissue of the body wallinto the body cavity. Endoscopic, laparoscopic and other suitableinstruments may then be directed through a housing located on theproximal end of the cannula to access the body cavity in a sealingmanner.

Compressible assemblies configured for accessing a body cavity andpermitting reception of instruments therethrough in sealing manner arealso known. Such compressible assemblies are composed of silicone,thermoplastic elastomers (TPE), rubber, foam, gel and other compressiblematerials and are configured to be compressed to facilitate insertioninto an incision. Typically, such assemblies are deformed by a surgeonusing his/her fingers or with the assistance of a grasping device, e.g.,forceps. Compression of the assembly reduces the profile of theassembly, thereby facilitating reception of the assembly into theincision. Upon release of the compressive force, the compressed assemblyreturns to an uncompressed configuration.

During application of a compressive force to the compressive accessassemblies, whether by hand or using an insertion device, excessivehandling may damage the assembly. Additionally, maintaining thecompressive force on the access assembly during installation andreapplying the compressive force during removal of the access assemblymay result in damage to surrounding tissue.

Therefore, it is desirable to provide an access assembly which iscapable of being received through an opening and removed therefrom withlimited compressive force.

SUMMARY

An assembly for accessing a body cavity is provided. The access assemblyincludes a flexible outer sleeve configured to be received through anopening in tissue. The outer sleeve defines a passageway therethroughand a notch formed about an inner surface thereof. The access assemblyfurther includes a support plate configured for selective receptionthrough the passageway of the outer sleeve and within the notch formedin the inner surface. The support plate defines at least a first openingconfigured to receive a surgical instrument therethrough. The opening inthe tissue may be an incision or a natural orifice.

In one embodiment, the outer sleeve is composed of at least one ofsilicone, thermoplastic elastomers (TPE), rubber, foam, gel. The supportplate may include multiple openings. The access assembly may furtherinclude a first cannula extending from the first opening in the supportplate. The first cannula may be selectively secured within the firstopening in the support plate. The first cannula may include a valveassembly. The valve assembly may include a valve member. The supportplate may be rotatable relative to the outer sleeve when the supportplate is operably received within the notch formed in the outer sleeve.

Also provided is a method of accessing a body cavity. The methodincludes the steps of providing an access assembly having an outersleeve and a support plate, flexing the outer sleeve to permit receptionof the outer sleeve through an opening in tissue, inserting thecompressed outer sleeve through tissue, permitting the compressed outersleeve to decompress within the opening, inserting the support plateinto the outer sleeve to cause unflexing of the outer sleeve and tocreate a seal within the opening, and manipulating one or moreinstruments through the access assembly to complete a procedure. Themethod may further include the step of creating an incision in tissuefor access to the body cavity.

DESCRIPTION OF THE DRAWINGS

Embodiments of a flexible access assembly are disclosed herein withreference to the drawings, wherein:

FIG. 1 is a perspective view of an embodiment of an access assemblyaccording to the present disclosure;

FIG. 2 is an exploded perspective view of the access assembly of FIG. 1;

FIG. 3 is a cross-sectional side view of the access assembly of FIGS. 1and 2;

FIG. 4 is a perspective view of the outer sleeve of the access assemblyof FIGS. 1-3, in a collapsed configuration;

FIG. 5 is a cross-sectional side view of the outer sleeve of FIG. 4,received through an incision in tissue;

FIG. 6 is a cross-sectional side view of the outer sleeve of FIGS. 4 and5 received through the incision and further including a support plate ofthe access assembly of FIGS. 1-3 received therein;

FIG. 7 is an enlarged partial view of a support plate according to analternative embodiment of the present disclosure;

FIG. 8 is an exploded perspective view of an access assembly accordingto an alternative embodiment of the present disclosure; and

FIG. 9 is a perspective side view of the access assembly of FIG. 8.

DETAILED DESCRIPTION

Embodiments of the presently disclosed access assembly will now bedescribed in detail with reference to the drawings wherein like numeralsdesignate identical or corresponding elements in each of the severalviews. As is common in the art, the term “proximal” refers to that partor component closer to the user or operator, e.g. surgeon or physician,while the term “distal” refers to that part or component further awayfrom the user. Although the access assemblies of the present disclosurewill be described as relates to accessing an abdominal cavity through anincision in the abdominal wall, the access assemblies of the presentdisclosure may be modified for use in other closed procedures, e.g.,laparoscopic, arthroscopic, endoscopic. Furthermore, the accessassemblies of the present disclosure may be modified for use inaccessing internal cavities through natural orifices, e.g., anus,vagina.

Referring initially to FIG. 1, an access assembly according to anembodiment of the present disclosure is shown generally as accessassembly 100. Access assembly 100 is configured for insertion through anopening in tissue, e.g., an incision, such that after insertion, accessassembly 100 creates a seal within the opening through which a surgeonmay insert and manipulate one or more surgical instruments to complete aprocedure.

With reference to FIGS. 1-3, access assembly 100 includes an outertissue seal or sleeve 110 and an inner support plate or disk 120. Sleeve110 and support disk 120 may be formed of various materials, such as,for example, silicone, thermoplastic elastomers (TPE), rubber, foam,gel, etc. Sleeve 110 and support plate 120 may be constructed from thesame or different materials. In one embodiment, sleeve 110 is formed ofa TPE material that is infused with an inert gas, e.g. CO₂ or Nitrogen,to form a foam structure, and inner support plate 120 is formed of asubstantially rigid thermoplastic elastomer, to form a substantiallysolid support structure.

Still referring to FIGS. 1-3, an outer surface 110 a of sleeve 110 maybe coated with a lubricant, e.g. Parylene N or C, in order to create alubricious surface and facilitate insertion of sleeve 110 into anincision “I” (FIG. 5). Outer sleeve additionally, or in the alternative,may be textured or may include a textured coating (not shown) forfacilitating engagement with tissue “T” about incision “I”. Variousother coatings, e.g., hydrophilic, hydrophobic, bio-agents,anti-infection, analgesic, may also be employed to improve thecharacteristics of access assembly 100 or to adapt access assembly 100for a specific procedure. Optionally, outer sleeve 110 may include aprotective outer layer (not shown). An inner surface 110 b of sleeve 110may be coated with a lubricant to facilitate insertion of support plate120 therein.

With particular reference now to FIGS. 2 and 3, sleeve 110 of accessassembly 100 defines a curved outer surface having open first and secondends 112, 114. First end 112 of outer sleeve 110 is configured to bereceived within a body cavity “C” (FIG. 5) of a patient. Although shownincluding having a circular cross-sectional profile, it is envisionedthat outer sleeve 110 may include other cross-sectional profiles,including oval. A rim or flange 116 is formed on first end 112 of outersleeve 110 about outer surface 110 a thereof. Although shown formedextending completely about outer surface 110 a of outer sleeve 110, rim116 may extend only partially and/or intermittently about outer surface110 a of outer sleeve 110. Second end 114 of outer sleeve 110 is flaredoutwardly and is configured to be maintained external of incision “I”.In one embodiment, flared second end 114 delineates the boundary throughwhich an instrument (not shown) inserted through access port 100 may bemanipulated without compromising the integrity of the seal betweenaccess assembly 100 and tissue “T”, between outer sleeve 110 and supportplate 120, and/or between support plate 120 and the instrument. Rim 116on first end 112 and flared second end 114 of outer sleeve 110 aid inpreventing longitudinal movement of access assembly 100 through incision“I” upon receipt of access assembly 100 within incision “I”.

As the thickness of tissue “T” depends on the body composition of thepatient and the location through which the underlying cavity is beingaccessed, the length and size of access assembly 100, generally, andouter sleeve 110, specifically, may be modified to suit a givenprocedure. In this manner, an adult patient having fatty abdominaltissue may require an access assembly 100 having a greater distancebetween first and second ends 112, 114 then an access assembly sized fora child. The flared configuration of second end 114 enables accessassembly 100 to be used on tissue ranging thickness. It is envisionedthat second end 114 of access assembly 100 may be configured forshortening by a clinician prior to or during a procedure in the eventouter sleeve 110 exceeds a necessary length.

With reference still to FIGS. 2 and 3, outer sleeve 110 defines alongitudinal opening 115 extending therethrough. As shown, longitudinalopening 115 includes a curved-tapered shape corresponding to the shapeof outer sleeve 110. Alternatively, opening 115 may be conical, steppedor otherwise configured to facilitate reception of support plate 120therein and passage of one or more instruments therethrough. Outersleeve 110 further includes an undercut structure defining a notch 117about inner surface 110 b on first end 112. Notch 117 is configured toselectively receive support plate 120 therein. Notch 117 may extendabout the entire inner surface of first end 112. Alternatively, notch117 may extend only partially and/or intermittently about the innersurface of first end 112. As seen in FIG. 5, notch 117 is positionednear first end 112 of outer sleeve 110 such that when outer sleeve 110is received through incision “I”, support plate 120 is positioned withinbody cavity “C”. In other words, support plate 120 is positioned belowtissue “T” when access assembly 100 is properly positioned withinincision “I”. However, it is envisioned that sleeve 110 may beconfigured such that notch 117, and thereby, support plate 120, arepositioned in horizontal alignment with tissue “T”, or alternatively,above of tissue “T”.

Still referring to FIGS. 2 and 3, support plate 120 of access assembly100 includes a cylindrical, substantially rigid body configured to bereceived through longitudinal opening 115 of sleeve 110 and within notch117. As shown, support plate 120 is substantially planar and includes acircular profile to correspond with the circular cross-sectional profileof outer sleeve 110, however, it is envisioned that support plate 120may be formed of varying thickness and may include a profile configuredto correspond with an outer sleeve of an alternative configuration.Support plate 120 is configured to be selectively received within notch117. In one embodiment, support plate 120 is configured to be rotatablewithin notch 117. In this manner, one or more surgical devices “D1”,“D2”, inserted therethrough, may be further manipulated during aprocedure.

Support plate 120 defines a pair of openings 122, 124. Cannulas 126, 128extend from openings 122, 124, respectively. As shown, cannulas 126, 128are securely affixed within respective openings 122, 124. In someembodiments, cannulas 126, 128 are configured to be selectively securedwithin openings 122, 124, respectively. For example, openings 122, 124may include a threaded proximal portion configured to engage threadedends (not shown) of cannula 126, 128, respectively. In this manner, theconfiguration of the cannulas used during a procedure may be selectedand/or interchanged by a clinician up to and during a procedure.Cannulas 126, 128 may be replaced or interchanged during a procedure tosatisfy the requirements of the procedure. In an alternative embodiment,126, 128 cannulas are integrally formed with support plate 120.

Cannulas 126, 128 each define a longitudinal passageway 127, 129,respectively, extending therethrough. Each of cannulas 126, 128 mayinclude a valve housing 130, 132, respectively. Each of valve housings130, 132 may include a valve member 134, 136, respectively. Each ofvalve members 134, 136 are configured to seal respective passageways127, 129 of cannulas 126, 128, respectively, in the absence of asurgical device “D1”, “D2” (FIG. 6) inserted therethrough. Each ofcannulas 126, 128 and valve housings 130, 132 may have the sameconfiguration for receiving instruments of similar configuration.Alternatively, the configurations of cannulas 126, 128 and valvehousings 130, 132, respectively, may differ. Although shown includingtwo (2) cannulas, 126, 128, it is envisioned that support plate 120 maybe provided without a cannula (FIG. 8), with only a single cannula orwith three (3) or more cannulas.

The use of access assembly 100 will now be described with reference toFIGS. 4-6. Although the following discussion will include using accessassembly 100 for accessing a body cavity “C” through an incision “I’, asdiscussed above, access assembly 100 may be used for accessing othercavities or lumen through other openings, including naturally occurringorifices, e.g., anus. Initially, an incision “I” (FIG. 5) is created intissue “T” through which access assembly 100 will be inserted to accessbody cavity “C”.

With reference to FIG. 4, support plate 120 is removed from outer sleeve110 in the event that outer sleeve 110 and support plate 120 are notprovided separate from each other. Once separated, outer sleeve 110 isradially and/or laterally compressed and/or folded to reduce thecross-section profile of outer sleeve 110 and to facilitate insertion offirst end 112 of outer sleeve 110 through incision “I”.

Turning to FIG. 5, once first end 112 of outer sleeve 110 is receivedthrough incision “I” such that rim 116 is received within body cavity“C”, outer sleeve 110 is permitted to return to an initial, uncompressedcondition. Outer sleeve 110 may only partially decompress withinincision “I” because of the force of tissue “T” against outer sleeve110. Support plate 120 is then inserted within passageway 115 of outersleeve 110 as outer sleeve 110 is maintained within incision “I” intissue “T”.

With reference to FIG. 6, insertion of support plate 120 within outersleeve 110 causes outer sleeve 110 to return to the initial,uncompressed and/or unfolded condition. Decompression or expansion ofouter sleeve 110 creates a seal between outer sleeve 110 and tissue “T”to prevent the escape of insufflation gas through incision “I”. Asdiscussed above, outer sleeve 110 and support plate 120 are alsoconfigured to form a seal therebetween to prevent the escape ofinsufflation gas from body cavity “C”.

With reference still to FIG. 6, once support plate 120 is received withouter sleeve 110, access assembly 100 operates in a traditional manner.Each of cannula 126, 128 are configured to selectively receive one ormore surgical devices “D1”, D2”. During a procedure, it is envisionedthat support plate 120 may be separated from outer sleeve 110 to permitthe removal of an organ or other tissue therethrough. Removal of supportplate 120 further permits the passage of larger instruments into cavity“C” through access assembly 100. While positioned through incision “I”in tissue “T”, access assembly 100 may be used to complete any number ofprocedures.

Removal of access assembly 100 from within incision “I” occurs in thereverse order of insertion. Initially, support plate 120 is separatedfrom outer sleeve 110. Outer sleeve 110 is then compressed to permitretraction from incision “I”. Alternatively, both inner core 120 andouter sleeve 110 may be compressed simultaneously such that accessassembly 100 may be removed as a single unit. Once access assembly 100is removed from incision “I”, incision “I” is closed in a conventionalmanner.

Turning now to FIG. 7, in an alternative embodiment, support plate 120defines a pair of openings 122, 124. Operably engaged within eachopening 122, 124 is a respective insert 123, 125. Inserts 123, 125 maybe securely affixed with openings 122, 124 using adhesive, welding,bonding or other suitable means. Alternatively, inserts 123, 125 may beselectively received within openings 122, 124. In one embodiment,inserts 123, 125 include proximal and distal flanges (not shown)configured for selectively engaging inner and outer surfaces 120 a, 120b of support plate 120. Inserts 123, 125 are formed of a material thatpermits movement of cannulas 126, 128, respectively, relative to supportplate 120, as indicated by arrows “A”, “B”, respectively. Inserts 123,125 are further configured to form a seal between support plate 120 andcannulas 126, 128. Cannulas 126, 128 may be securely affixed to inserts123, 125. Alternatively, cannulas 126, 128 are selectively positionableand/or removable from inserts 123, 125. In this manner, cannulas 126,128 may be repositioned and/or replaced. Although shown with cannulas126, 128 received through respective inserts 123, 125, it is envisionedthat inserts 123, 125 may instead be configured to receive one or moreinstruments therethrough. In this manner, inserts 123, 125 may include aseal member (not shown) for sealing respective openings 122, 124 in theabsence of an instrument inserted therethrough. As discussed above,support plate 120 may be configured to be rotated within outer sleeve110 along a longitudinal axis “x”, as indicated by arrows “C”.

With reference now to FIGS. 8 and 9, an alternative embodiment of anaccess assembly according to the present disclosure is shown generallyas access assembly 200. Access assembly 200 is substantially similar toaccess assembly 100 described hereinabove, and will therefore only bedescribed as relates to the differences therebetween. Access assembly200 includes an outer sleeve 210 and a support plate 220. First end 212of outer sleeve 210 includes a generally tapered configurationconfigured to be received through an incision “I”. First end 212includes an undercut structure defining a notch 217. First end 212further includes a flange portion 216.

As seen in FIG. 8, in a first or initial condition, e.g., in the absenceof support plate 220, flange portion 216 extends radially inward. Inthis manner, first end 212 of outer sleeve 210 is configured for ease ofreception within an incision “I”. As seen in FIG. 9, in a secondcondition, e.g., upon receipt of support plate 220 therein, outer sleeve210 is configured such that flange portion 216 and first end 212 thereofflare radially outward. In this manner, flange portion 216 aids inpreventing longitudinal movement or retraction of access assembly 200through incision “I” upon receipt of access assembly 200 within incision“I”.

With reference still to FIG. 8, support plate 220 includes a pluralityof openings 222, 224, 226. Each of openings 222, 224, 226 may include acannula (not shown) and/or an insert (not shown), as discussed above.Alternatively, openings 222, 224, 226 may be left open. Support plate220 includes a tab 225 or other suitable structure configured toselectively engage an insertion device 50. Insertion device 50 may beselectively attached to support plate 220 to facilitate insertion ofsupport plate 220 within notch 217 of outer sleeve 210. Separation ofinsertion device 50 from tab 225 creates spaces within outer sleeve 210for greater manipulation of instruments inserted through openings 222,224, 226.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the support plate may form anannular member having a single opening therethrough to facilitatepassage of an oversized surgical device therethrough. Therefore, theabove description should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1. An access assembly comprising: a flexible outer sleeve configured tobe received through an opening in tissue, the outer sleeve defining apassageway therethrough and a notch formed about an inner surfacethereof; and a support plate configured for selective reception throughthe passageway of the outer sleeve and within the notch formed in theinner surface, the support plate defining at least a first openingconfigured to receive a surgical instrument therethrough.
 2. The accessassembly of claim 1, wherein the outer sleeve is composed of at leastone of silicone, thermoplastic elastomers (TPE), rubber, foam, gel. 3.The access assembly of claim 1, wherein the support plate includesmultiple openings.
 4. The access assembly of claim 1, wherein thesupport plate includes three openings.
 5. The access assembly of claim1, further including a first cannula extending from the first opening inthe support plate.
 6. The access assembly of claim 5, wherein the firstcannula is selectively secured within the first opening in the supportplate.
 7. The access assembly of claim 5, wherein the first cannulaincludes a valve assembly.
 8. The access assembly of claim 7, whereinthe valve assembly includes a valve member.
 9. The access assembly ofclaim 1, wherein the opening in the tissue is an incision.
 10. Theaccess assembly of claim 1, wherein the opening in tissue is a naturalorifice.
 11. The access assembly of claim 1, wherein the support plateis rotatable relative to the outer sleeve when the support plate isoperably received within the notch formed in the outer sleeve.
 12. Amethod of accessing a body cavity, the method comprising the steps of:providing an access assembly having an outer sleeve and a support plate;flexing the outer sleeve to permit reception of the outer sleeve throughan opening in tissue; inserting the compressed outer sleeve throughtissue; permitting the compressed outer sleeve to decompress within theopening; inserting the support plate into the outer sleeve to causeunflexing of the outer sleeve and to create a seal within the opening;and manipulating one or more instruments through the access assembly tocomplete a procedure.
 13. The method of claim 12, further including thestep of creating an incision in tissue for access to the body cavity.